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Global Postural Reeducation in Chronic Low Back Pain (GPR)

Primary Purpose

Back Pain, Mechanical Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control Group
Global Reeducation Group
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring chronic low back pain, Postural global reeducation, randomized, physical rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • between 18-65 years age,
  • low back pain (more than 12 weeks) without legs irradiation,
  • pain between 3-8 cm on a visual Analogue scale (0-10cm).

Exclusion Criteria:

  • fibromyalgia,
  • pregnancy,
  • osteoporosis severe,
  • disc herniation,
  • patients who had undergone spinal surgical or physiotherapeutic interventions within 3 months prior to baseline assessment.

Sites / Locations

  • São Paulo Federal University UNIFESP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Postural Reeducation Group

Control Group

Arm Description

The participants, after obtaining a written informed consent, were randomized for one of the two groups: In the Global Postural Reeducation group (GPR), they were submitted 1 time per week, during 12 weeks, at GPR sessions. The duration of sessions was 60 minutes each, with the same physical Therapist of the study. After the intervention, subjects returned to assessment 3 months after, with the blinded assessor. All the 6 postures from GPR were used during the study. All outcomes measurements, in both groups, were validated for Portuguese language and applicable at baseline, 3 months and 6 months after baseline.

In the control group, no physical intervention was given during the study. After the study, 6 months after, all participants from control group received the same treatment given in GPR group, according to the Unifesp Ethics Committee orientations. All participants, of both groups, have a doctor from the study, if necessary.

Outcomes

Primary Outcome Measures

Change from baseline in pain
The primary outcome of this study was the measurement of pain assessed with 0-10cm Visual Analogue Scale (VAS). They were collected at baseline and two follow-up examinations after 3 and 6 months from baseline.

Secondary Outcome Measures

Change from baseline in function
The secondary outcome included function measured by Roland Morris Questionnaire. It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.

Full Information

First Posted
March 13, 2012
Last Updated
March 15, 2012
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01557049
Brief Title
Global Postural Reeducation in Chronic Low Back Pain
Acronym
GPR
Official Title
Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain.
Detailed Description
Approximately 80-85% of individuals will experience low back pain during their lifetime. It is one of the major concerns of current health care. There is evidence for the effectiveness of exercise therapy in patients with chronic low back pain. GPR is a physical therapy method developed in France by Philippe Emmanuel Souchard. Although this method is largely used as form of treatment in most countries, few studies showed its clinical effectiveness in chronic low back pain. This is the first randomized controlled trial, with assessor blind that evaluate the GPR effects in chronic low back pain. All outcome measurements are reliability, validated and sensitivity for statistical changes using the Visual Analogic Scale- VAS (0-10cm), Roland Morris Questionary, SF36 (Quality Life Questionary) and Beck Scale (Depression Symptoms).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Mechanical Low Back Pain
Keywords
chronic low back pain, Postural global reeducation, randomized, physical rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postural Reeducation Group
Arm Type
Experimental
Arm Description
The participants, after obtaining a written informed consent, were randomized for one of the two groups: In the Global Postural Reeducation group (GPR), they were submitted 1 time per week, during 12 weeks, at GPR sessions. The duration of sessions was 60 minutes each, with the same physical Therapist of the study. After the intervention, subjects returned to assessment 3 months after, with the blinded assessor. All the 6 postures from GPR were used during the study. All outcomes measurements, in both groups, were validated for Portuguese language and applicable at baseline, 3 months and 6 months after baseline.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
In the control group, no physical intervention was given during the study. After the study, 6 months after, all participants from control group received the same treatment given in GPR group, according to the Unifesp Ethics Committee orientations. All participants, of both groups, have a doctor from the study, if necessary.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
No physical intervention was given, patients were treated only with medication if necessary.
Intervention Type
Other
Intervention Name(s)
Global Reeducation Group
Intervention Description
They were treated with medication if necessary and performed GPR session once a week, during 12 weeks. All the 6 postures from GPR were used during the study.
Primary Outcome Measure Information:
Title
Change from baseline in pain
Description
The primary outcome of this study was the measurement of pain assessed with 0-10cm Visual Analogue Scale (VAS). They were collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
Time Frame
baseline and two follow-up examinations - after 3 and 6 months from baseline
Secondary Outcome Measure Information:
Title
Change from baseline in function
Description
The secondary outcome included function measured by Roland Morris Questionnaire. It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
Time Frame
It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: between 18-65 years age, low back pain (more than 12 weeks) without legs irradiation, pain between 3-8 cm on a visual Analogue scale (0-10cm). Exclusion Criteria: fibromyalgia, pregnancy, osteoporosis severe, disc herniation, patients who had undergone spinal surgical or physiotherapeutic interventions within 3 months prior to baseline assessment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscila Maria Lawand, Author
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
São Paulo Federal University UNIFESP
City
São Paulo
ZIP/Postal Code
04023-900
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.sbrpg.com.br/
Description
Postural Global Reeducation Society
URL
http://www.unifesp.br
Description
São Paulo Federal University

Learn more about this trial

Global Postural Reeducation in Chronic Low Back Pain

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